Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening (FIX-SDM LCS)

The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:

• Does the patient and provider support increase the number of patients who complete lung cancer screening?
• Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening?
• Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening.

Primary care provider participants will:

• Receive the provider support session and educational materials, or follow usual practice
• Answer a baseline survey and a follow-up survey in 6 months
• Answer additional survey questions regarding the acceptability of the provider support session if they receive it

Patient participants will

• Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care
• Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Cancer Screening
• Intervention / Treatment: Behavioral: FIX-SDM; Behavioral: Usual Care

Detailed Description

Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).

The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • University of Massachusetts Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Primary care provider (PCP) participants:

Inclusion criteria

• PCPs (physicians or advanced practitioners)
• Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
• Who care for more than 5 potentially LCS-eligible patients in their practice Exclusion criteria
• Participation in the previous study to co-develop the provider intervention (to avoid bias)

Patient participants

Inclusion Criteria:

• Adults between the ages of 50 and 77
• Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)
• Has a smartphone with texting capability
• English-speaking
• Has a scheduled PCP visit in the next ~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study

Exclusion Criteria:

• Prior LCS
• Chest CT within the last 12 months
• History of lung cancer
• Active cancer requiring treatment
• Supplemental oxygen use
• Pregnancy
• Participation in the previous study to co-develop the patient intervention (to avoid bias)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIX-SDM; Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.	Behavioral: FIX-SDM; Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
Active Comparator: Comparator: Usual Care; PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care.	Behavioral: Usual Care; PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of Lung Cancer Screening (LCS) within 3 months	The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit	3 months after the index visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion of LCS within 6 months	The proportion of patients in each arm who completed LCS within 6 months of the index primary care visit	6 months after the index visit
LCS order	The proportion of patients in each arm who had a LCS order in the electronic health record (EHR)	3 and 6 months after the index visit
LCS appointment	The proportion of patients in each arm who had an appointment for LCS scheduled in the EHR	3 and 6 months after the index visit
Patient-reported LCS discussion	The proportion of patients in each arm who had LCS discussions with providers during their visits, assessed by the patient survey items	Within 10 days after the index visit
Content of LCS discussion	The mean number of LCS topics discussed during the visits, assessed by the patient survey items in each arm	Within 10 days after the index visit
Patient perceived quality of LCS discussion	The mean score of the Patient Assessment of Cancer Communication Experiences (PACE) survey in each arm	Within 10 days after the index visit
Patient-reported shared decsion making (SDM) for LCS	The mean score of the SDM Process 4, assessed during the patient survey in each arm	Within 10 days after the index visit.
Patient knowledge of LCS	The mean number of LCS knowledge question items answered correctly in each arm, assessed during the patient survey in each arm	Within 10 days after the index visit.
Patient decisional conflict	The mean score of the Decisional Conflict Scale in each arm, assessed during the patient survey in each arm	Within 10 days after the index visit and 3 months after the index visit
Patient acceptability of FIX-SDM	Acceptability of FIX-SDM among patients in the FIX-SDM arm, assessed by the survey items	Within 10 days after the index visit.
Patient decision satisfaction	Patient decision satisfaction in each arm assessed by a 10-point Likert scale	3 months after the index visit
Patient decision regret	Patient decision regret in each arm assessed by the Decision Regret Scale	3 months after the index visit
Patient decision intention to follow-up LCS	Patient decision intention to adhere to follow-up LCS in each arm, assessed by a 5-point Likert scale	3 months after the index visit
Provider acceptability of FIX-SDM	Acceptability of FIX-SDM among providers in the FIX-SDM arm, assessed by provider survey items	Immediately after the PCP intervention
Provider report on decision aid use	Frequency of decision aid use measured by a 5-point Likert scale in each arm	6 months after the provider baseline survey
Provider reports on the content of the LCS discussion	Frequency of the content of LCS discussion measured by a 5-point Likert scale in each arm	6 months after the provider baseline survey
Sustainability of shared decision making for LCS	Sustainability of shared decision-making for LCS assessed by the Normalization Measure Development Questionnaire in a provider survey in each arm	6 months after the provider baseline survey

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mayuko Ito Fukunaga, MD, MSc, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Shared Decision Making; Lung Cancer Screening; health informatics
• Other Study ID Numbers: STUDY00001107; 5K08CA283304 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: With an executed Data Use Agreement, a limited data set may be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No